NCT05807217

Brief Summary

This study was a single-center, open clinical study in Chinese septic patients with or without acute kidney injury. The aims of this study were to obtain the blood concentration and pharmacokinetic parameters of meropenem and piperacillin, exosome information and endogenous biomarker, and to explore the functional changes of OATs under the condition of sepsis and acute kidney injury.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 11, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

February 6, 2023

Last Update Submit

March 28, 2023

Conditions

SepsisAcute Kidney Injury

Keywords

sepsisorganic anion transporteracute kidney injuryquantitative pharmacologyanti-infective drug

Outcome Measures

Primary Outcomes (4)

  • Plasma concentration of meropenem

    Baseline and within 24 hours after administration

  • Dialysate concentration of meropenem

    One day

  • Plasma concentration of piperacillin

    Baseline and within 24 hours after administration

  • Dialysate concentration of piperacillin

    One day

Secondary Outcomes (1)

  • Plasma concentration of pyridoxic acid

    Baseline

Study Arms (5)

Group A

12 patients (receiving meropenem) without acute kidney injury

Group B

12 patients (receiving meropenem) without renal replacement therapy for acute kidney injury

Group C

12 patients (receiving meropenem) with intermittent renal replacement therapy for acute kidney injury

Group D

4 patients (receiving meropenem) with continuous renal replacement therapy for acute kidney injury

Group E

4 patients (receiving piperacillin) with intermittent renal replacement therapy for acute kidney injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese septic patients with or without acute kidney injury

You may qualify if:

  • Male or female, aged above 18 years old;
  • Diagnosed with sepsis or septic shock;
  • Body mass index (BMI) between 15-32 kg/m2 (male with the weight of \> 45 kg and female with the weight of \> 40 kg);
  • Patients should be able to understand and sign the ICF voluntarily (if one has no capacity for civil conduct, the guardian will sign on behalf of him) and comply with the research restrictions.
  • A diagnosis of AKI by the criteria of KDIGO for Group B, C, D and E;
  • The pathogenic pathogen isolated or judged by attending physician to be susceptible to meropenem or piperacillin.
  • RRT can be performed for Group C, D and E.

You may not qualify if:

  • Be allergic to carbapenems and other β-lactam drugs or a history of allergy to those drugs;
  • Currently diagnosed as malignant tumor;
  • Women who are pregnant or breastfeeding;
  • Receiving ECMO during RRT;
  • Patients with severe liver insufficiency (Child-Pugh grade C);
  • Patients with eGFR of \< 15 mL/min/1.73 m2 and receive regular dialysis treatment;
  • A history of alcohol or drug abuse or a behavior of alcohol or drug abuse within the past six months;
  • Patients who have taken or injected probenecid, gentamicin and streptomycin within 14 days before administration;
  • Patients who have taken or injected vitamin B6 for 14 days before administration to the trial period;
  • Poor peripheral venous access or intolerance to venous blood collection;
  • Meet one of the following conditions: human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen positive (except C antibody was positive), hepatitis C virus (HCV) or syphilis positive;
  • Patients who had a history of kidney transplantation or nephrectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood cell

MeSH Terms

Conditions

SepsisAcute Kidney Injury

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ning shen

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongyang Liu

CONTACT

(86)010-82266658liudongyang@vip.sina.com

Hao Liang

CONTACT

13426217031lianghao86@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director, Department of Respiratory and Critical Care Medicine

Study Record Dates

First Submitted

February 6, 2023

First Posted

April 11, 2023

Study Start

October 26, 2022

Primary Completion

November 30, 2023

Study Completion

December 31, 2023

Last Updated

April 11, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)